Feasibility and Validation of a Standard Phenotyping Assessment Battery

NCT03495869 | Completed Results

• 2 other identifiers: HM20012559U54DA038999
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this project is to collect preliminary data on psychosocial measures and behavioral performance comparing individuals with Opioid Use Disorder, Cocaine Use Disorder, dual diagnosis of Opioid and Cocaine Use Disorder, and Healthy Controls in an effort to determine overall feasibility of a phenotypic "fingerprint" for cohorts of individuals with addictions for use during clinical trials.

Conditions

Opioid-use Disorder; Cocaine Use Disorder; Marijuana Use Disorder; Healthy Controls

Outcome Measures

Primary Outcomes (1)

• Retention

  Number of dropouts

  1 month

Secondary Outcomes (2)

• Time to Complete Battery

  5 hours

• Non-completers of the Battery and Platform Instruments

  5 hours

Other Outcomes (7)

• Performance on Measures of Cognition Across Conditions

  5 hours

• Performance on Measures of Reward Processing Across Conditions

  5 hours

• Performance on Measures of Negative Emotionality Across Conditions

  5 hours

Study Arms (4)

Individuals with Cocaine Use Disorder

This group will consist of individuals who are determined to have DSM5 diagnosis of Cocaine Use Disorder (n=50). Individuals will be recruited from an existing registry (VCU IRB HMHM20000294, Keyser-Marcus, PI)

Individuals with Opioid Use Disorder

This group will consist of individuals who are determined to have DSM5 diagnosis of Opioid Use Disorder (n=200).

Individuals with Marijuana Use Disorder

This group will consist of individuals who are determined to have DSM5 diagnosis of Marijuana Use Disorder (n=50).

Healthy Controls

This group will consist of individuals who are determined to be non-drug using healthy controls (n=100).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study utilizes a four-group cross sectional cohort design. A total of 400 participants (across 4 cohorts) are targeted to complete the study) to include: Healthy Controls (n=100), individuals with CocUD (n=50), individuals with OUD (n=200), and individuals with MJUD (n=50).

You may qualify if:

• Males and females between 18 and 70 years-of-age.
• Current DSM-5 primary Substance Use Disorder: Opioid, marijuana, stimulants (individuals with multiple types of substance use (e.g., opioid/marijuana will be included)
• Have no contraindications for study participation as determined by medical history and concomitant medications.
• Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.
• Be able and willing to comply with scheduled visits, and other study procedures.
• Be able to read and complete forms and interviews in English.
• Males and females between 18 and 70 years of age.
• Have no contraindications for study participation as determined by medical history and concomitant medications.
• Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory testing.
• Be able and willing to comply with scheduled visits, and other study
• Be able to read and complete forms and interviews in English.

You may not qualify if:

• Current psychosis, mania, or suicidal/homicidal ideation
• Have a history of seizures (excluding childhood febrile seizures), or loss of consciousness from traumatic injury for more than 30 minutes.
• Have any other illness, or condition, which in the opinion of the PI or study physician would preclude safe and/or successful completion of the study.
• Metal fragments or implants, and/or history of fear of being in closed spaces for MRI scans.
• Currently pregnant or nursing.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

VCU Institute for Drug and Alcohol Studies

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Lori Keyser-Marcus, PhD
• Organization: Virginia Commonwealth University

lori.keysermarcus@vcuhealth.org

(804) 828-4164

Study Officials

• Lori Keyser-Marcus, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 12, 2018
• Study Start: June 21, 2018
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: August 4, 2021
• Results First Posted: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)